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Geron Corporation Announces the Pricing of its Public Offering of Common Stock and Warrants

On May 22, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the pricing of its previously announced underwritten public offering of 107,049,375 shares of its common stock and pre-funded warrants to purchase 8,335,239 shares of common stock, together with accompanying warrants to purchase 57,692,307 shares of common stock (Press release, Geron, MAY 22, 2020, View Source [SID1234558417]). The common stock and pre-funded warrants will be sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The combined offering price to the public of each share of common stock and accompanying warrant is $1.30. The combined offering price to the public of each pre-funded warrant and accompanying warrant is $1.299.

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All of the securities in the offering are being sold by Geron. The gross proceeds to Geron from this underwritten public offering are expected to be approximately $150 million, before deducting the underwriting discount and other estimated offering expenses payable by Geron. The offering is expected to close on or about May 27, 2020, subject to the satisfaction of customary closing conditions.

Geron intends to use the net proceeds from this public offering to fund its ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes to top-line results, its planned Phase 3 clinical trial in refractory myelofibrosis to complete patient enrollment, and for working capital and general corporate purposes.

Stifel and MTS Health Partners are acting as joint book-running managers for the offering. Needham & Company, BTIG and H.C. Wainwright & Co are acting as co-managers for the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and accompanying warrants described above was filed with the Securities and Exchange Commission (SEC) and is effective. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from the offices of Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected]; or MTS Securities, LLC, 623 Fifth Avenue, 14th Floor, New York, New York 10022, by telephone at 646-975-6548 or by email at [email protected].

Bayer submits larotrectinib for marketing authorization in Japan for the treatment of TRK fusion cancer

On May 22, 2020 Bayer reported that it has submitted an application for marketing authorization for its precision oncology treatment larotrectinib to the Ministry of Health, Labor and Welfare (MHLW) in Japan (Press release, Bayer, MAY 22, 2020, View Source [SID1234558416]). Larotrectinib is an oral TRK inhibitor that has been developed specifically to treat adults and children with locally advanced or metastatic solid tumors that have the rare genomic alteration called a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The product is already approved in several countries under the brand name Vitrakvi, including the U.S., Brazil, Canada and countries of the European Union (EU). Filings in other regions are underway or planned.

"With this submission, we are one step closer to providing patients and physicians in Japan with a highly selective treatment exclusively designed for adults and children with TRK fusion cancer, that has the potential to significantly improve treatment outcomes regardless of tumor type or patient age," said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer’s Pharmaceutical Division. "While cancers have previously been treated mainly in the body, larotrectinib was developed specifically to treat patients with TRK fusion cancer, regardless of where in the body the tumor originates. Larotrectinib represents an important advancement in the fight against this rare cancer, as it could replace costly treatment that is not targeted specifically to this cancer and does not have proven efficacy and safety in this patient population."

The submission to the MHLW is based on clinical trial data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, cholangiocarcinoma, soft tissue sarcomas, salivary gland and infantile fibrosarcoma.

TRK fusion cancer is rare overall. It affects both children and adults and occurs in varying frequencies across various tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering the activation of an intercellular signaling cascade. These TRK fusion proteins act as oncogenic drivers that fuel the spread and growth of the patients’ cancer, regardless of where it originates in the body.

About larotrectinib
Larotrectinib, a specific oral TRK inhibitor, was exclusively designed to treat tumors that have an NTRK gene fusion. The compound has demonstrated high response rates and durable responses with a favorable safety profile over three years in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors. It has the largest dataset and longest follow-up data of any TRK inhibitor. The trials are still ongoing, with the latest dataset published in The Lancet Oncology and additional updates planned to be presented at upcoming scientific meetings.

Larotrectinib was approved in September 2019 in the European Union under the brand name Vitrakvi for the treatment of adult and pediatric patients with solid tumors that display an NTRK gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. Vitrakvi has also received regulatory approval in additional markets, including the U.S, Brazil and Canada. Filings in other regions are underway or planned.

Following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019, Bayer has obtained the exclusive licensing rights for the global development and commercialization, including in the U.S., for larotrectinib and the investigational another TRK inhibitor selitrectinib (BAY 2731954) progressing through clinical development.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Pfizer Inc. Recommends Rejection of Unsolicited Note Tender Offer by Huguenot Bond Liquidity, LLC

On May 22, 2020 Pfizer Inc. (NYSE: PFE) reported that it and Wyeth recommend rejection of the unsolicited tender offer made by Huguenot Bond Liquidity, LLC ("Offeror") on May 11, 2020 (as amended and restated on May 21, 2020) to purchase up to $162.5 million principal amount of Pfizer’s outstanding 7.200% notes due 2039 (the "Pfizer Notes") and up to $130.0 million principal amount of Wyeth’s 5.950% notes due 2037 (the "Wyeth Notes" and together with the Pfizer Notes, the "Notes") (Press release, Pfizer, MAY 22, 2020, View Source [SID1234558414]). Wyeth is a wholly-owned subsidiary of Pfizer. Pfizer and Wyeth do not endorse Offeror’s unsolicited tender offer, and neither Pfizer nor Wyeth is affiliated or associated with the Offeror, the tender offer or the offer documentation. The Offeror did not inform Pfizer of the tender offer, and Pfizer only became aware of the offer through a third party source. Further, there is no disclosure of information regarding the Offeror or any indication as to a source of financing for the offer in the offer documentation.

Pfizer arrived at this position after considering all of the facts and circumstances surrounding the Offeror’s unsolicited tender offer. In particular, Pfizer believes that the tender offer is not in the best interest of the holders of the Notes for the following reasons, among others:

the applicable tender consideration offered by the Offeror, as calculated using a reference date of May 21, 2020, is approximately 7% lower than the last trade price of $166 per $100 principal amount of notes for the Pfizer Notes and approximately 8% lower than the last trade price of $145 per $100 principal amount of notes for the Wyeth Notes, in each case on May 21, 2020, the last business day prior to the issuance of this press release;
the tender consideration is variable and is based on a benchmark security that may trade based on factors independent of those that may affect the trading prices of the Notes; and
the consummation of the offer is subject to a number of conditions and Offeror has retained a right to terminate the tender offer if any of these conditions are not satisfied or, in its absolute discretion, at any time and for any reason, reducing the likelihood that the offer will be consummated.
The announcements contained in this press release were made pursuant to Pfizer and Wyeth’s obligations under Rule 14e-2 under the Securities Exchange Act of 1934. Pfizer and Wyeth are not taking a position on whether the unsolicited tender offer is being made in accordance with United States federal securities laws, including the applicable rules and regulations issued by the Securities and Exchange Commission.

Pfizer urges investors to obtain current market quotations for their Notes, to consult with their broker or financial advisor and to exercise caution with respect to the Offeror’s offer. Pfizer recommends that noteholders who have not responded to the Offeror’s offer take no action. Holders of Notes who have already tendered their Notes may withdraw them at any time prior to May 26, 2020, in accordance with the Offeror’s offering documents. The tender offer is currently scheduled to expire at 5:00 pm New York City time on Tuesday, June 9, 2020.

Pfizer requests that a copy of this news release be included with all distributions of materials relating to the Offeror’s offer related to the Notes.

Molecular Templates, Inc. Announces $45 Million Debt Financing From K2 HealthVentures

On May 22, 2020 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," "MTEM" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported it has secured a debt financing facility for up to $45 million from K2 HealthVentures, a healthcare-focused specialty finance company (Press release, Molecular Templates, MAY 22, 2020, View Source [SID1234558412]). MTEM received a first tranche of $15 million upon closing, a portion of which has been used to repay the remaining indebtedness that was outstanding under the Company’s prior credit facility. Two subsequent tranches totaling up to $30 million will become available to MTEM, at its option, upon the achievement of certain milestones with respect to the second tranche and, subject to lender consent and certain additional conditions with respect to the third tranche.

"This debt facility strengthens our balance sheet in a non-dilutive fashion and increases our financial flexibility as we advance and expand our pipeline and grow our internal manufacturing capacity," said Eric Poma, Ph.D. Molecular Templates’ Chief Executive and Scientific Officer.

Kitov Announces U.S. FDA Acceptance of Investigational New Drug Application to Conduct Phase 1/2 Clinical Trial of NT219 in Multiple Types of Advanced Cancer Patients

On May 22, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical trial of NT219, a novel agent addressing treatment resistance in advanced cancer (Press release, Kitov Pharmaceuticals , MAY 22, 2020, View Source [SID1234558411]). The study will evaluate NT219 as monotherapy treatment of advanced solid tumors and in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

"The acceptance of our IND by the FDA to conduct this important clinical study represents a significant achievement for our NT219 development program," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov. "Based on the encouraging preclinical data generated in various studies with NT219, we believe this promising drug candidate has the potential to be a safe and effective therapy for multiple treatment resistant cancers. We look forward to beginning to generate key clinical evidence for NT219 through this Phase 1/2 trial."

The primary objectives of the open-label Phase 1/2 trial are to evaluate safety, assess pharmacokinetics, identify the appropriate dose to be studied in the Phase 2 portion, and establish preliminary efficacy of NT219. The Phase 1 portion of the study will encompass a dose escalation evaluation of NT219 monotherapy administered weekly in patients with refractory advanced solid tumors. Upon reaching the third dose to be given, a second cohort of patients, with either recurrent or metastatic squamous cell carcinoma of the head and neck or colorectal adenocarcinoma, will be dosed weekly with NT219, dose escalated, in combination with cetuximab. Upon completion of the mono and combination therapy Phase 1 portion of the trial and establishment of the recommended Phase 2 dose for NT219, an expansion Phase 2 component of the study will be commenced at the recommended Phase 2 dose of NT219 in combination with cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

In previously completed preclinical studies, NT219 has demonstrated compelling anti-tumor activity, as both monotherapy and in combination with cetuximab. Most recently, in an abstract published at the American Association of Cancer Research Virtual Meeting II website, positive preclinical data were presented showing that NT219 demonstrated growth inhibition, both as monotherapy, as well as in combination with cetuximab or pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor, in multiple patient-derived xenograft models of subjects with head and neck squamous cell carcinoma.